NCT06172556

Brief Summary

the goal of this type of study : observation study is to learn about cerebral edema and hematoma in aneurysmal subarachnoid hemorrhage the main questions it aims to answer are current clinical practices lack predictive models to identify early structural brain abnormalities affecting cognition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 7, 2023

Last Update Submit

December 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Description of subarachnoid blood on cranial CT

    No visible blood, no effacement, and no widening of the longitudinal fissure of the brain. Absence of visible sulci due to effacement, diffuse deposits, or thin layers of blood at specified brain locations (L-FPN or D-FPN or M-FPN or PN or ON or M-CIN or other), or widening of the longitudinal fissure. Localized/diffuse blood deposits (\<1 mm thick) at specified locations (L-FPN or D-FPN or M-FPN or PN or ON or M-CIN or other) in each section, without visible sulci in those areas at two predetermined levels in each hemisphere. For specified locations (L-FPN or D-FPN or M-FPN or PN or ON or M-CIN or other) in each section, absence of visible sulci at two predetermined levels in each hemisphere or disruption of the grey-white matter junction, with blood pooling (\<1 mm thick) in ventricles or cerebral pools (insular pools, circumferential pools, lateral fissure pools, interpeduncular pools, lateral ventricles). Disappearance of sulci at two predetermined levels in each hemisphere or local

    24 - 48 hours

Interventions

Endovascular coiling, Surgical clipping, Mix

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Han Chinese emergency call

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 05000, China

Location

Related Publications (1)

  • Wang MD, Fu QH, Ni A, Yuan YP, Li CH, Wang ZX, Wang H. The role of early cerebral edema and hematoma assessment in aneurysmal subarachnoid hemorrhage (a-SAH) in predicting early brain injury (EBI) and cognitive impairment: a case controlled study. Int J Surg. 2024 Jun 1;110(6):3166-3177. doi: 10.1097/JS9.0000000000001244.

Biospecimen

Retention: SAMPLES WITHOUT DNA

brain CT\& MRI

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mingdong Wang

    The First Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Associate Chief Physician

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

April 1, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations